Does NCCAM's"Priority Setting
Framework" for 2011-2015 Focus on Researching "Products"? A Message
and Clarification from Dr. Briggs

Summary: The recently published "priority-setting
framework" for the 2011-2015 NIH NCCAM strategic plan left the strong
impression that the agency had merged with the Office of Dietary
Supplements.
The short statement in a April
16, 2010
"Message from the Director" by
Josephine
Briggs, MD focused on investigating "products." The term denotes the
field of integrative practice 3 times in the short guide. Adding to
this
apparent pigeon-holing are repeated highlights of basic science
questions
and efficacy trials and the absence of any allusion to outcomes
research or whole disciplines. In short, the published framework
appears
more appropriate for exploring
conventional pharmaceuticals than multi-modality, whole person
approaches. I contacted Briggs with
some pointed
questions, referencing NCCAM's Congressional mandate. Here
is Briggs' NCCAM framework, my questions, and her letter
in
response.

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In an April 2010 Message
from
the
Director, Josephine Briggs, MD, director of the NIH National
Center for Complementary and Alternative Medicine (NCCAM) offers "a
priority-setting framework to help determine which research directions
to
pursue" in the 2011-2015 strategic plan. (Bold is added.)

"Science: Is there clear scientific
opportunity in
studying this product? Are there methods and technologies available
that
permit rigorous studies to clarify biological mechanism and ultimately
clinical
efficacy?

"Promise: Is there a body of
evidence indicating that the
product has the potential to contribute to treat troublesome or
prevalent
health conditions or symptoms? Or is there evidence it acts on a
biological pathway of importance in health and disease?

"Use: Is the natural product in
widespread use? Does
the research address a public health concern regarding efficacy,
safety,
or lack thereof?

"Impact: Will the research have
scientific or public
impact?"

_____________________________

Does the agency's 1998 Congressional mandate fit in its 2010 priority framework?

The choice of words in this framework were
startling if not dismaying for those who think NCCAM would best serve
the public by charting a course that more closely reflects actual
integrative practices.

Repeated in this document is reference to the evaluation of
"products." Integrative practitioners,
who may use natural products in their practices, don't describe what
they do in "product" language. Nor are mind-body interventions typically
described as "products," unless perhaps one is referencing CDs or
DVDs. Acupuncturists do not view themselves as "products,"
even if they merely needle.

This is not quibbling over semantics. The
language
from the Director project the NIH's pharmaceutical
bias over
the holistic, whole person integrative practice landscape.

Notably, when Congress established NCCAM in 1998, the focus was not on
products. Rather, Congress created NCCAM to
examine "complementary
and
alternative
treatment,
diagnostic and prevention modalities,
disciplines
and systems." This phrase, or an analog, was used 6 times in the short
mandate. The
word "product" does not
appear. Nor do the terms "herbs" or
"vitamins" or "supplements" or "natural products."
This is not quibbling over semantics. The language
from Briggs projects NIH's pharmaceutical bias over
the holistic, whole person integrative practice research landscape. This
reiteration of the reductive agenda which defined the first decade of
NCCAM's mechanism and natural drug-trial priorities is underscored by the
two references each to mechanism and to efficacy trials.

Does this language, consciously or unconsciously, capture
the
thinking inside NCCAM as the 2011-2015 strategic plan is near completion? If so, NCCAM
appears to be taking a huge step backward from the new
"effectiveness"
direction and emerging interest in "real
world
outcomes" about which
Briggs' has spoken. I summarized my concerns in a April 26, 2010
electronic message to Briggs. (See bottom of this article for my
full query.) Here is Briggs' response.

_____________________________

Response of NCCAM's Briggs on Questionson the "Products" Focus in the Priority Setting Framework

[Received by e-mail, April 27, 2010]

Briggs: Clarifying misleading language

"Thank you for your note
and for reading the message so carefully. Indeed, it is not our
intention to
only study products, but more broadly to encourage research on CAM
practices,
disciplines, and whole systems- as well as products. The language
suggesting a
focus on natural products was quite inadvertent; in fact, there are
many
important CAM interventions that would not be labeled as products.

"The larger message I was trying to convey
is that, through our strategic planning process and extensive community
input,
we are developing a framework by which to prioritize our research in a
methodical and systematic way. As you know, there are many different
perspectives about where NCCAM should focus our research efforts, and
having
such a framework ensures that we continue to be neutral and objective
in
our
approach.

"The language
suggesting a
focus on natural products was quite inadvertent; in fact, there are
many
important CAM interventions that would not be labeled as products."

"NCCAM recognizes the unique and important
roles for basic, clinical, as well as outcome (real world
effectiveness)
research. While natural product research may need to focus more on
mechanistic
research, mind-body interventions may need more focus on outcome
research.

"This type of dialogue helps us to hone our
strategic thinking and how we communicate to our stakeholders.

Comment: First, I thank Briggs for her prompt response. She
continues her pattern of communicating with NCCAM's remarkably diverse
set of stakeholders, on which I
commented recently. I am sure that my queries are not always the
most pleasant part of her day. No doubt her life is full of pushes and
pulls from many corners. It is an honor to be considered a a valued participant in this important dialogue.

How differently this "priority-setting
framework"would
have read had Briggs
merely appropriated and internalized
the language Congress gave
NCCAM
for prioritizing its agenda.

Yet while Briggs' clarification is pleasing, it fails to expunge my concern.
Slips of language are meaningful. Freud said that. I would guess that
such slips as these would be far more likely in a researcher, like
Briggs, who joins the field without
prior connection with "CAM" or integrative medicine. "Products" is
the native language of her home country. It's her comfort language, just as "whole practices" and "treating the whole person" and "holistic" are my own, having lived inside them for nearly 3 decades.

While there is no doubt that Briggs has quite laudably met with practitioners of all kinds during the 27 months of her
entry into the field, this slip makes me wonder how deeply new thinking has
penetrated. Has she taken a Berlitz course or realized that her great success must be via immersion into new cultures and disciplines?

I would not continue to hold my concern in reserve had the original
framework in any way acknowledged all that it omitted. Read it once for its exclusions. Happily, Briggs
alludes to outcomes and disciplines and real world research and whole systems in her response. But she
needs to trumpet this new agenda. A similar situation was formerly with the cialis side effects. Her signature
strategic plan needs to be remedial. Under her predecessor, NCCAM liked
"products," basic research and efficacy trials to the near
exclusion of outcomes. And we left that era with many wondering about the value of the Center.

How differently this "priority-setting framework" would have read had Briggs
merely appropriated and internalized the language Congress gave
NCCAM for prioritizing its agenda. The bold is the language of Congress.

Science: Is there clear scientific opportunity
in
studying
this complementary and
alternative treatment,
diagnostic and prevention modality, discipline or systems?

Promise: Is there a body of evidence
indicating that
the complementary
and alternative treatment,
diagnostic and prevention modality, discipline or systems have
the potential to contribute to treat troublesome or prevalent health
conditions or symptoms?

Use: Is the complementary
and alternative treatment,
diagnostic and prevention modality, discipline or systems in widespread use?

.

At this late moment,
this triple
slip-of-the-tongue
remains deeply troubling.

As we move precipitously close to the
unveiling of NCCAM's draft strategic plan, scheduled for release in June 2010, we need declarations that a significant share of
NCCAM's resources will target real world questions. "Balance" in investment, as urged by Consortium
of Academic Health Centers for Integrative Medicine, would suggest $35-$45-million each year of NCCAM's $120-million. So far we have
little evidence that NCCAM is
contemplating anything close to that.

This is hard. Briggs may be the best leader NCCAM could have in this moment, all things considered. She has won the respect and support of many. Yet at this late moment, this triple slip-of-the-tongue remains deeply troubling.

________________________________

Weeks' Query Letter to NCCAM Director Briggs

[Sent April 26, 2010.]

"I have questions regarding the message from the director. In the
priority
setting framework you reference studying "product"

"... As we develop our next strategic plan, we've
created a priority-setting framework to help determine which research
directions to pursue:

Science: Is there clear scientific opportunity in
studying
this product?
Are there methods
and technologies available that permit rigorous studies to clarify
biological mechanism and ultimately clinical efficacy?

Promise: Is there a body of evidence indicating that the
product
has the
potential to contribute to treat troublesome or prevalent health
conditions or symptoms? Or is there evidence it acts on a biological
pathway of importance in health and disease?

Use: Is the natural
product in widespread use? Does the research address a
public health concern regarding efficacy, safety, or lack thereof?

Impact: Will the research have scientific or public
impact?

My questions are:

1. "Product" is typically meant
to be a thing that a practitioner uses as an agent, as in "natural
product" - herb or supplement or drug. Is this what you are indicating
here? If not, why this language?

2. In the NCCAM mandate which you reference
in your white papers on the strategic plan, there is no reference to
studying
"products." Rather, Congress repeatedly focuses the Center
on investigating "alternative treatment, diagnostic and prevention
modalities, disciplines and systems." How are researchers and
stakeholders
to reconcile the language in the framework with this mandate? What
reason
would they have to feel that NCCAM is interested in "diagnostic and
prevention modalities, disciplines and systems"?

3. In the NCCAM mandate, basic
research is in a list as #4 of 6 types of research, and RCTs/efficacy
trials as
#5. These follow outcomes #1 and health services research #3. The
"science" portion of the framework directly references basic research
(mechanism) and RCTs (efficacy trials) only. How is this reconciled
with
the
focus of the mandate? How are those who are interested in studying
outcomes of
interventions via "disciplines and systems" to feel that this
includes them?

4. Again, under the "promise"
portion of the framework, the focus is on basic research ("biological
pathways"). How again are those interested in exploring outcomes from
examining disciplines and systems and preventive approaches.

5. Again, the "use" portion also
focuses on efficacy trials. Is this an indication that NCCAM will
continue to
elevate RCTs above outcomes in the 2011-2015 plan?

My questions are not only about the inclusion
of
"product" language and focus on basic and efficacy research around
which the framework is built. It is also about exclusion
in your chosen language of other ways of research. For
instance, might you have used this language to describe the framework:

Science: Is there clear scientific opportunity in
studying
this complementary and
alternative treatment,
diagnostic and prevention modalities, disciplines and systems?
Are there methods and technologies available that permit rigorous
studies
to clarify biological mechanism and ultimately clinical efficacy?

Promise: Is there a body of evidence indicating that
the complementary
and alternative treatment,
diagnostic and prevention modalities, disciplines and systems has
the potential to contribute to treat troublesome or prevalent health
conditions or symptoms? Or is there evidence it acts on a biological
pathway of importance in health and disease?

Use: Is the complementary
and alternative treatment, diagnostic and prevention modalities,
disciplines and systems in widespread use? Does the
research address a public health concern regarding efficacy, safety,
or
lack thereof?

Thank you for your time, and clarity. I
am
sure the many provider stakeholder organizations that have urged NCCAM
to
explore real world outcomes and research on whole practices will be
interested
in your response.

I plan to publish this April 29 - at the latest May 3, and so would
appreciate
a response as soon as possible. Thank you.

John

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